FDA.reportPublic FDA data

ONLINE TDM Phenobarbital

Primary DI
07613336121467
Brand
ONLINE TDM Phenobarbital
Company
Roche Diagnostics GmbH
Model
08058580190
Catalog number
08058580190
Published
2020-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DLZENZYME IMMUNOASSAY, PHENOBARBITAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLZEnzyme Immunoassay, PhenobarbitalClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071644000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071644000ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620Roche Diagnostics Corp.2007-09-12DLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336121467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336121467076133361214677613336121467

GMDN Terms#

Term, Definition table
TermDefinition
Phenobarbital IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of phenobarbital in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10758750004560VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DLZ2021-11-08
00380740154110AlinityABBOTT LABORATORIESDLZ2018-11-12
00630414595993Atellica CH PhnbSiemens Healthcare Diagnostics Inc.DLZ2017-12-22
05055273206401PHBRANDOX LABORATORIES LIMITEDDLZ2016-09-24
00842768005596Dimension® Flex® reagent cartridge PHNOSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768015397Dimension Vista® Flex® reagent cartridge PHNOSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768017407Syva® Emit® 2000 Phenobarbital AssaySiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768017414Syva® Emit® 2000 Phenobarbital CalibratorsSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00842768023224Emit® 2000 Phenobarbital AssaySiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414527192ADVIA Centaur® PHNBSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414527208ADVIA Centaur® Systems, ACS:180® Systems PHNB CalibratorSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414527215ADVIA Centaur® Systems Phenobarbital CalibratorSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414561929ADVIA® Chemistry PHNB_2 Phenobarbital_2 ReagentsSiemens Healthcare Diagnostics Inc.DLZ2016-09-24
00630414961828IMMULITE® 2000 Systems PHE PhenobarbitalSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDLZ2016-09-24
00630414964379IMMULITE®/IMMULITE® 1000 Systems PHE PhenobarbitalSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDLZ2016-09-24
04015630997060ONLINE TDM PhenobarbitalRoche Diagnostics GmbHDLZ2016-09-20
04015630999316PhenobarbitalRoche Diagnostics GmbHDLZ2016-09-20
04015630999323PhenobarbitalRoche Diagnostics GmbHDLZ2016-09-20
00884883001237CEDIA Phenobarbital II AssayMicrogenics CorporationDLZ2016-09-12
00380740001773ARCHITECTABBOTT LABORATORIESDLZ2016-06-06
00380740001780ARCHITECTABBOTT LABORATORIESDLZ2016-06-06
00380740102692ARCHITECTABBOTT LABORATORIESDLZ2016-06-06